Baxter International‘s Preflucel vaccine has shown a near 80% efficacy in protecting against influenza strains, a Phase III study has shown.
The results, published in The Lancet, indicated that participants responded positively to the vaccine, with 78.5% protective efficacy against culture-confirmed influenza infection and robust immune responses, against the three viral strains contained in the vaccine, including A/H1N1, A/H3N2 and B-specific.
The randomised, double-blind, placebo-controlled trial was involved more than 7,200 healthy volenteers in the US during the 2008/2009 influenza season.
Barts and the London School of Medicine and Dentistry professor John Oxford said: “Seasonal influenza claims thousands of lives every year, but can be very effectively prevented through wide-spread vaccination.
“This study provides important new information that Baxter’ Vero cell-derived seasonal vaccine is well-tolerated, immunogenic and efficacious and should be considered when planning public health preventive efforts around flu season.”
In addition to protection, investigators found significantly reduced duration and severity of influenza symptoms in infected subjects in the vaccinated group, as compared with the placebo group in a subsequent analysis.
Preflucel is available in Austria and the Czech Republic for the 2010 to 2011 influenza season and Baxter expects to receive approval of the vaccine in other European countries this year.